FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
WOUND DRAINAGE HOLDER
K Number: K973183
·
Decision Jan 23, 1998
Classifications
1
FEI Numbers
214
Registration Numbers
214
Same Product Code
28
Applicant Total
4
Review Days
151
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Basic Information
- Device Name
- WOUND DRAINAGE HOLDER
- K Number
- K973183
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4200
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- R & D Medical Products, Inc.
- Date Received
- August 25, 1997
- Decision Date
- January 23, 1998
- Product Code
- KGZ
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KGZ | Accessories, Catheter | FDA class 1 | General, Plastic Surgery |
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